Sharp Mint Limited
Form 483 issued January 31, 2020 · New Delhi, India
- Inspection
- Jan 27 – Jan 31, 2020
- Investigator
- Lata Mathew
- Observations
- 5
- Pages
- 6
- FEI number
- 3004293539
In short: On January 31, 2020, FDA issued a Form 483 with 5 observations to Sharp Mint Limited in New Delhi, Delhi (FEI 3004293539) after an inspection that ran Jan 27 – Jan 31, 2020. The investigator was Lata Mathew. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to implement an on-going stability testing program to monitor the stability characteristics of API, confirm…
- 02
Failure of the QA unit to evaluate the effect of…
- 03
Failure to test the identity of each batch…
- 04
Failure to ensure that all employees…
This inspection in context
Lata Mathew
24 documents · 2017–2024
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmSharp Mint Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sharp Mint Limited?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, production and materials. The opening words of each observation are shown on this page.
Who inspected Sharp Mint Limited?
Lata Mathew is named on this Form 483, for the inspection of Jan 27 – Jan 31, 2020. Each investigator has a profile showing what they cite most.
When was Sharp Mint Limited inspected by FDA?
The inspection ran Jan 27 – Jan 31, 2020, and the Form 483 is dated January 31, 2020.
How do I get the full Form 483 for Sharp Mint Limited?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.